After Lynn Brown’s daughter, Amanda, was diagnosed in 1999 with a childhood form of brain cancer, the 16-year-old endured multiple surgeries, weeks of radiation, months of chemotherapy and numerous blood transfusions — not to mention intense pain.
Doctors initially prescribed morphine, and when that became less effective over time, they switched to a relatively new drug: OxyContin.
“It made her treatments bearable,” said Brown, who lives in Miami. “I knew it was a powerful drug. . . . But you have to weigh the circumstances. You have to deal with the situation you’re given.”
Doctors weaned Amanda off the potent narcotic after several months. Now 32, she has survived cancer, graduated from college and recently gotten married.
She is the sort of patient the Food and Drug Administration had in mind last month when it approved OxyContin, an extended-release form of the opioid painkiller oxycodone, for children as young as 11 who need “daily, round-the-clock, long-term” pain relief that can’t be treated adequately with other medications.
The decision was welcomed by some pediatricians and pain specialists, but it also provoked fierce criticism. On social media, people accused the FDA of acting irresponsibly and putting the interests of OxyContin’s manufacturer, Purdue Pharma, ahead of the welfare of children, who they worried would become addicted to the drug.
Sen. Joe Manchin III (D-W.Va.), whose state has been especially hard hit by the epidemic of prescription drug and heroin abuse, wrote a scathing letter, telling the FDA it “should be absolutely ashamed of itself for this reckless act.” He warned that the decision could lead to “poisoning our children’s brains and setting them up for future drug abuse,” and called for a Senate investigation into the decision.
The FDA, in its defense, says its recent approval for 11- to 16-year-olds wasn’t intended to expand the use opioids in children but, rather, to give doctors better guidelines about how to use OxyContin safely in pediatric patients. Doctors can already prescribe medications any way they see fit, and many physicians have long given OxyContin and other potent painkillers “off label” to children suffering from cancer, major surgeries or other trauma, the agency said.
Prior to the approval, the FDA asked Purdue to perform studies evaluating the safety and effectiveness of OxyContin in pediatric patients. FDA officials said the results supported the use of the drug in limited situations — such as when intractable pain couldn’t be treated effectively with less powerful painkillers.
“We understand there is a terrible problem with opioid abuse and addiction,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “But this is about evidence-based medicine for children — seriously ill children who are suffering pain.”
Woodcock noted that nearly two decades ago, Congress created incentives for manufacturers to conduct more studies of drugs in children, in part so that doctors would know when to give a medication to a child, and what dose to use. She said the effort has led to new labeling on 535 drugs to include pediatric indications.
The FDA’s reasoning has done little to mollify such critics as Andrew Kolodny, a New York psychiatrist and director of Physicians for Responsible Opioid Prescribing.
Kolodny said the agency failed to sufficiently weigh the risk of addiction, which is greater in young brains that aren’t fully developed. And he says the new approval will lead to Purdue, the drug’s manufacturer, to market OxyContin more broadly.
“You’re talking about a privately held company where executives have faced criminal charges for the way they marketed OxyContin,” he said. “You’re giving a company with a very bad track record permission to market this drug for children. I think they’re going to take advantage of that.”
He said the agency should have convened a public advisory committee hearing to consider the issue, given the crisis involving the abuse of prescription painkillers. He said there are rare circumstances when giving opioids to children is warranted, but he said the FDA’s decision does nothing to expand access to those patients, given that doctors already are free to prescribe the drug in those situations.
Meanwhile, Purdue insists it has no plans to market the drug for a pediatric population. In a statement, the company said it “will not promote to pediatricians or other physicians the new pediatric safety and dosing information for OxyContin. This decision is based on our commitment to combatting the overuse, misuse and abuse of prescription opioids.”
In a separate letter to Manchin, Purdue’s chief medical officer, Gail Cawkwell, made a similar vow.
“We would like to assure you that Purdue will not promote to pediatricians or other physicians the new pediatric dosing and safety information for OxyContin,” Cawkwell wrote. “This company accepted responsibility for its past actions, and since that time Purdue has led our industry in the development of technologies and programs intended to combat the abuse and misuse of prescription drugs.”
Purdue and several of its executives in 2007 pleaded guilty to falsely marketing OxyContin in a way that played down the drug’s risk of addiction and potential for abuse. The company and the executives paid about $635 million to resolve criminal and civil charges related to the misbranding.
Sharon Hertz, director of the FDA’s division of anesthesia, analgesia and addiction products, said the agency is requiring Purdue to conduct follow-up studies on how OxyContin is being used in young patients.
Gary Walco, director of pain medicine at Seattle Children’s Hospital, said he doesn’t see the FDA’s decision on OxyContin for children as inherently good or bad. Pediatricians and patients, he said, benefit from research on when and how to prescribe medications. “I am a firm believer in relying on data to drive clinical practice,” he said.
At the same time, Walco said: “We have learned from the adult world that opioids are often prescribed inappropriately. . . . It is critical that anyone prescribing this medication to children and adolescents be intimately familiar with the limitations of the data and the nuances of prescribing.”
District resident Peter Brown understands concerns that the FDA’s recent approval could worsen the epidemic of opioid abuse. But as a parent who saw his only child, Matthew, die at age 7 in 2009 after an excruciating bout with bone cancer, Brown also sees it as a necessary step. His son received OxyContin and several other painkillers after undergoing chemotherapy and a series of invasive surgeries to remove cancer from his limbs and his lungs.
“I understand the controversy,” said Brown, who along with his wife, Victoria, runs the locally based Mattie Miracle Cancer Foundation. “Regulation is needed, and public safety is very important. . . . [But] when your child is in pain . . . it’s sort of a no-brainer to have this available.”